UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045981 |
|---|---|
| Receipt number | R000052360 |
| Scientific Title | A study on effective training of the vastus intermedius muscle using a simple evaluation method |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2026/05/13 11:01:11 |
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Basic information
Public title
A study on effective training of the vastus intermedius muscle using a simple evaluation method
Acronym
A study on effective training of the vastus intermedius muscle using a simple evaluation method
Scientific Title
A study on effective training of the vastus intermedius muscle using a simple evaluation method
Scientific Title:Acronym
A study on effective training of the vastus intermedius muscle using a simple evaluation method
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
First, to elucidate the relationship between the intermediate frequency of the surface electromyogram, which is conventionally used as an indicator of muscle fatigue, and muscle edema captured by ultrasound imaging, which may be used as a new and simple indicator of muscle fatigue, secondly, to clarify the most effective knee joint angle for isometric training of vastus intermedius using muscle edema as an outcome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the percentage change in muscle thickness using ultrasound imaging equipment.
Other outcomes are intermediate frequency (MF) and maximal knee extensor strength using surface electromyography.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patient must be a healthy person with no history of orthopedic disease of the knee or hip joint and no limitation of range of motion of the knee or hip joint.
Key exclusion criteria
The applicant must have an obvious or pre-existing orthopedic disease of the knee or hip joint.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | sho |
| Middle name | |
| Last name | kumabe |
Organization
aino University
Division name
Department of Physical Therapy, Faculty of Medical and Health Sciences
Zip code
567-0012
Address
4-5-4, Higashiota, Ibaraki City, Osaka, Japan
TEL
072-627-1711
s-kumabe@pt-u.aino.ac.jp
Public contact
Name of contact person
| 1st name | sho |
| Middle name | |
| Last name | kumabe |
Organization
aino University
Division name
Department of Physical Therapy, Faculty of Medical and Health Sciences
Zip code
567-0012
Address
4-5-4, Higashiota, Ibaraki City, Osaka, Japan
TEL
072-627-1711
Homepage URL
s-kumabe@pt-u.aino.ac.jp
Sponsor or person
Institute
Kiou University
Institute
Department
Personal name
Funding Source
Organization
Aino University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aino University
Address
4-5-4, Higashiota, Ibaraki City, Osaka, Japan
Tel
0745-54-1601
s-kumabe@pt-u.aino.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
60
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The research design is a cross-sectional study.
Management information
Registered date
| 2021 | Year | 11 | Month | 04 | Day |
Last modified on
| 2026 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052360
